A Pre-market, Two-stages Interventional Clinical Investigation to Evaluate the Safety and the Performance of Fibroin Syrup in Reducing the Gastroesophageal Reflux Disease (GERD) Symptomatology in Nonerosive Reflux Disease (NERD) Patients

NCT07563790 | Completed

• 1 other identifier: RF-FibroinS-2024
• Study Type: interventional
• Target: 47
• Locations: 1 country
• Sites: 1

Brief Summary

This study involves a medical device in the form of syrup, not yet on the market and tested for the first time in humans, named "FIBROIN SYRUP". The intended use is to reduce the GastroEsophageal Reflux Disease (GERD) symptoms such as heartburn, epigastric pain, irritative and nocturnal cough, dysphagia and dysphonia, which may occur especially after meals or during the night due to lying position. "FIBROIN SYRUP" has never been tested on humans and this study aims to evaluate the safety, tolerability and efficacy of the medical device when taken after the main meals (breakfast, lunch, and dinner; total: 3 sticks/day) for 6 weeks.

Conditions

Gastroesophageal Reflux (GERD); GERD (Heartburn, Regurgitation, and Dyspepsia)

Keywords

GastroEsophageal Reflux GERD

Outcome Measures

Primary Outcomes (1)

• To evaluate the safety and the tolerability of FIBROIN SYRUP. Safety and the tolerability will be monitored through vital signs.

  Safety will be monitored through Blood pressure measurement. Blood pressure readings are typically expressed in millimeters of mercury (mmHg)

  V-1 (within 7 days before V0); V0 (day 0) V1 (6 week from V0) V2 (12 weeks form V0)

Secondary Outcomes (5)

• To evaluate the performance of the "FIBROIN SYRUP" in reducing the gastroesophageal symptomatology in NERD patients.

  V0 (day 0) V1 (6 week from V0) V2 (12 weeks form V0)

• To evaluate the patient's satisfaction

  V2 (12 weeks form V0)

• The Safety and the tolerability will be monitored through the reporting of the adverse events, serious adverse events and concomitant medications during the entire study duration.

  V-1 (within 7 days before V0); V0 (day 0) V1 (6 week from V0) V2 (12 weeks form V0)

• To evaluate the safety and the tolerability of FIBROIN SYRUP. Safety and the tolerability will be monitored through vital signs.

  V-1 (within 7 days before V0); V0 (day 0) V1 (6 week from V0) V2 (12 weeks form V0)

• To evaluate the safety and the tolerability of FIBROIN SYRUP. Safety and the tolerability will be monitored through vital signs.

  V-1 (within 7 days before V0); V0 (day 0) V1 (6 week from V0) V2 (12 weeks form V0)

Study Arms (1)

Adult patients suffering from gastroesophageal reflux disease

EXPERIMENTAL

Device: Syrup made by hyaluronic acid

Interventions

Syrup made by hyaluronic acid DEVICE

Syrup made by hyaluronic acid that forms a protective layer that adheres to the esophageal mucosa and has a mechanical action

Adult patients suffering from gastroesophageal reflux disease

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patient who signed Informed consent form;
• Male or Female over 18 years old at the time of the signature of the Informed consent form;
• Symptomatic non-erosive reflux disease (heartburn and/or regurgitation) for at least 8 weeks;
• RDQ (Reflux Disease Questionnaire) score ≥ 12 at baseline (questionnaire specific for reporting the frequency and severity of upper gastrointestinal symptoms);
• Willingness to follow all study procedures, including attending all site visits, tests and examinations.

You may not qualify if:

• Esophagitis according to the Los Angeles classification (grade A to D);
• Diagnosis of Helicobacter pylori infection;
• Use of proton pump inhibitors or H2 receptor antagonists in the previous 4 weeks;
• Uncontrolled cardiac, renal, liver or pulmonary disease;
• Diabetes;
• Active malignant neoplasia;
• Pregnancy or breast-feeding;
• Known allergy to device components;
• Known drug and/or alcohol abuse;
• Mental incapacity that precludes adequate understanding or cooperation.

Sponsors & Collaborators

• Rose Pharma SA: lead

Study Sites (1)

UOC Medicina Interna Cardiovascolare - Centro Endoscopia Digestiva - Policlinico di Sant'Orsola - Bologna

Bologna, BO, 40121, Italy

Location

MeSH Terms

Conditions

Gastroesophageal Reflux; Heartburn; Dyspepsia

Condition Hierarchy (Ancestors)

Esophageal Motility Disorders; Deglutition Disorders; Esophageal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Medical device under form of syrup with a mechanical action

Study Record Dates

• First Submitted: November 27, 2025
• First Posted: May 4, 2026
• Study Start: July 24, 2024
• Primary Completion: July 31, 2025
• Study Completion: August 8, 2025
• Last Updated: May 4, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)